| (III) beyond-use date as determined by the pharmacist
using appropriate documented criteria as outlined in paragraph (5)(C)
of this subsection; and
(IV) quantity or amount in the container.
(C) Commercially available products may be compounded
for dispensing to individual patients provided the following conditions
are met:
(i) the commercial product is not reasonably available
from normal distribution channels in a timely manner to meet patient's
needs;
(ii) the pharmacy maintains documentation that the
product is not reasonably available due to a drug shortage or unavailability
from the manufacturer; and
(iii) the prescribing practitioner has requested that
the drug be compounded as described in subparagraph (D) of this paragraph.
(D) A pharmacy may not compound preparations that are
essentially copies of commercially available products (e.g., the preparation
is dispensed in a strength that is only slightly different from a
commercially available product) unless the prescribing practitioner
specifically orders the strength or dosage form and specifies why
the patient needs the particular strength or dosage form of the preparation.
The prescribing practitioner shall provide documentation of a patient
specific medical need and the preparation produces a clinically significant
therapeutic response (e.g. the physician requests an alternate product
due to hypersensitivity to excipients or preservative in the FDA-approved
product, or the physician requests an effective alternate dosage form)
or if the drug product is not commercially available. The unavailability
of such drug product must be documented prior to compounding. The
methodology for documenting unavailability includes maintaining a
copy of the wholesaler's notification showing back-ordered, discontinued,
or out-of-stock items. This documentation must be available in hard-copy
or electronic format for inspection by the board.
(E) A pharmacy may enter into an agreement to compound
and dispense prescription/medication orders for another pharmacy provided
the pharmacy complies with the provisions of §291.125 of this
title (relating to Centralized Prescription Dispensing).
(F) Compounding pharmacies/pharmacists may advertise
and promote the fact that they provide non-sterile prescription compounding
services, which may include specific drug products and classes of
drugs.
(G) A pharmacy may not compound veterinary preparations
for use in food producing animals except in accordance with federal
guidelines.
(H) A pharmacist may add flavoring to a prescription
at the request of a patient, the patient's agent, or the prescriber.
The pharmacist shall label the flavored prescription with a beyond-use-date
that shall be no longer than fourteen days if stored in a refrigerator
unless otherwise documented. Documentation of beyond-use-dates longer
than fourteen days shall be maintained by the pharmacy electronically
or manually and made available to agents of the board on request.
A pharmacist may not add flavoring to an over-the-counter product
at the request of a patient or patient's agent unless the pharmacist
obtains a prescription for the over-the-counter product from the patient's
practitioner.
(2) Library. In addition to the library requirements
of the pharmacy's specific license classification, a pharmacy shall
maintain a current copy, in hard-copy or electronic format, of Chapter
795 of the USP/NF concerning Pharmacy Compounding Non-Sterile Preparations.
(3) Environment.
(A) Pharmacies engaging in compounding shall have a
designated and adequate area for the safe and orderly compounding
of non-sterile preparations, including the placement of equipment
and materials.
(B) Only personnel authorized by the responsible pharmacist
shall be in the immediate vicinity of a drug compounding operation.
(C) A sink with hot and cold running water, exclusive
of rest room facilities, shall be accessible to the compounding areas
and be maintained in a sanitary condition. Supplies necessary for
adequate washing shall be accessible in the immediate area of the
sink and include:
(i) soap or detergent; and
(ii) air-driers or single-use towels.
(D) If drug products which require special precautions
to prevent contamination, such as penicillin, are involved in a compounding
operation, appropriate measures, including dedication of equipment
for such operations or the meticulous cleaning of contaminated equipment
prior to its use for the preparation of other drug products, must
be used in order to prevent cross-contamination.
(E) Cleaning and sanitizing of surfaces in the non-sterile
compounding area(s) shall occur on a regular basis as defined in appropriate
SOPs as outlined in paragraph (8)(A) of this subsection.
(4) Equipment and Supplies. The pharmacy shall:
(A) if the pharmacy engages in compounding non-sterile
preparations that require weighing a component of the preparation,
have a Class A prescription balance, or analytical balance and weights
which shall be calibrated and have the accuracy of the balance verified
by the pharmacy at least every 12 months as specified in the pharmacy's
SOPs. The pharmacy shall document the calibration and verification;
and
(B) have equipment and utensils necessary for the proper
compounding of prescription drug or medication orders. Such equipment
and utensils used in the compounding process shall be:
(i) of appropriate design and capacity, and be operated
within designed operational limits;
(ii) of suitable composition so that surfaces that
contact components, in-process material, or drug products shall not
be reactive, additive, or absorptive so as to alter the safety, identity,
strength, quality, or purity of the drug product beyond the desired
result;
(iii) cleaned and sanitized immediately prior to and
after each use; and
(iv) routinely inspected, calibrated (if necessary),
or checked to ensure proper performance.
(5) Labeling. In addition to the labeling requirements
of the pharmacy's specific license classification, the label dispensed
or distributed pursuant to a prescription drug or medication order
shall contain the following.
(A) The generic name(s) or the official name(s) of
the principal active ingredient(s) of the compounded preparation.
(B) A statement that the preparation has been compounded
by the pharmacy. (An auxiliary label may be used on the container
to meet this requirement).
(C) A beyond-use date after which the compounded preparation
should not be used. The beyond-use date shall be determined as outlined
in Chapter 795 of the USP/NF concerning Pharmacy Compounding Non-Sterile
Preparations including the following:
(i) The pharmacist shall consider:
(I) physical and chemical properties of active ingredients;
(II) use of preservatives and/or stabilizing agents;
(III) dosage form;
(IV) storage containers and conditions; and
(V) scientific, laboratory, or reference data from
a peer reviewed source and retained in the pharmacy. The reference
data should follow the same preparation instructions for combining
raw materials and packaged in a container with similar properties.
(ii) In the absence of stability information applicable
for a specific drug or preparation, the following maximum beyond-use
dates are to be used when the compounded preparation is packaged in
tight, light-resistant containers and stored at controlled room temperatures.
(I) Nonaqueous liquids and solid formulations (Where
the manufactured drug product is the source of active ingredient):
25% of the time remaining until the product's expiration date or 6
months, whichever is earlier.
(II) Water-containing formulations (Prepared from ingredients
in solid form): Not later than 14 days when refrigerated between 2
- 8 degrees Celsius (36 - 46 degrees Fahrenheit).
(III) All other formulations: Intended duration of
therapy or 30 days, whichever is earlier.
(iii) Beyond-use date limits may be exceeded when supported
by valid scientific stability information for the specific compounded
preparation.
(6) Written drug information. Written information about
the compounded preparation or its major active ingredient(s) shall
be given to the patient at the time of dispensing. A statement which
indicates that the preparation was compounded by the pharmacy must
be included in this written information. If there is no written information
available, the patient should be advised that the drug has been compounded
and how to contact a pharmacist, and if appropriate the prescriber,
concerning the drug.
(7) Drugs, components, and materials used in non-sterile
compounding.
Cont'd... |
